Comparing the pharmacokinetics, safety, and immunogenicity of HLX02 to US- and EU-approved trastuzumab in healthy Chinese male subjects: A Phase I, randomized, double-blind, parallel-group study-Reference-Cited by-同舟云学术

Comparing the pharmacokinetics, safety, and immunogenicity of HLX02 to US- and EU-approved trastuzumab in healthy Chinese male subjects: A Phase I, randomized, double-blind, parallel-group study

Published:2023-02-26 Issue:8 Volume:23 Page:717-725
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Zhou Wenjia¹,Wang Meng¹,Yu Yunli¹,Wang Ji²,Wu Yanni³,Yang Guiyu⁴,Yu Haoyu⁴,Li Jing⁴,Zhou Liang⁴,Zhang Quanying¹

Affiliation:

1. Phase 1 Clinical Trial Center, the Second Affiliated Hospital of Soochow University, Suzhou, Shanghai, China

2. Department of Medical Oncology, the Second Affiliated Hospital of Soochow University, Suzhou, Shanghai, China

3. Department of Cardiology, the Second Affiliated Hospital of Soochow University, Suzhou, Shanghai, China

4. Shanghai Henlius Biotech, Inc, Shanghai, Shanghai, China

Funder

Shanghai Henlius Biotech, Inc

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2023.2183117

Reference26 articles.

1. The oncogene HER2: its signaling and transforming functions and its role in human cancer pathogenesis

2. Trastuzumab — Mechanism of Action and Use in Clinical Practice

3. The development and clinical use of trastuzumab (Herceptin).

4. Genentech. Herceptin (trastuzumab) US Prescribing Information (November 2018). July 2022]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf.

5. Roche. Herceptin (trastuzumab) EU Summary of Product Characteristics (September 2021). July 2022]; Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin.

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